Capture assembly and method

ABSTRACT

This patent document discloses assemblies and methods for removing obstructive material from a body vessel or other cavity. An assembly can include an elongate inner member, an elongate outer member, an aspirator, one or more valves, or a waste collection reservoir. Each of the elongate members can extend from a proximal end portion to a distal end portion and can include a lumen therethrough. The elongate inner member can be partially disposed in the lumen of the elongate outer member and can be moveable along its longitudinal axis relative to the elongate outer member. The aspirator can be in flow communication with the proximal end portion of the elongate inner member for drawing the obstructive material into or through its lumen. The one or more valves can be configured and positioned to allow obstructive material removed from the body vessel or cavity to be urged toward the waste collection reservoir.

CLAIM OF PRIORITY

This non-provisional patent document is a continuation of U.S. patentapplication Ser. No. 14/849,774, entitled “CAPTURE ASSEMBLY AND METHOD”and filed Sep. 10, 2015, which claims the benefit of priority under 35U.S.C. §119(e) to U.S. Provisional Patent Application Ser. No.62/048,736, entitled “THROMBECTOMY ASSEMBLY AND METHOD” and filed onSep. 10, 2014, both of which are herein incorporated by reference intheir entirety.

TECHNICAL FIELD

This patent document relates to medical devices. More particularly, butnot by way of limitation, the patent document relates to object captureassemblies and methods of capturing and removing objects from a bodylumen, particularly for the capture and removal of obstructive materialfrom a patient's vasculature.

BACKGROUND

Occlusive diseases of the vasculature are a leading cause of mortalityand morbidity. While the nature of vascular diseases varies greatly, theunderlying clinical cause is a reduction in blood flow due to anaccumulation of obstructive material in one or more vessels feeding ordraining an affected organ. The obstructive material can vary inhardness and composition. Harder obstructive material often containscalcified atherosclerotic plaque, whereas softer obstructive materialoften contains blood clots (thrombi), and vascular disease is commonlycaused by a combination of the two.

Obstructive material is often found in the peripheral circulatory systemas well as the coronary vessels. When such obstructions develop abruptlyin one or more coronary vessels feeding the heart, a heart attack canoccur. When obstructions develop over a longer period in one or morecoronary vessels, patients can experience angina; while developingobstructions in one or more peripheral vessels can result in patientpain, ulcers, or gangrene in an extremity. When the blockage of bloodflow becomes sufficiently serious, it is necessary to intervene andrecanalize the affected blood vessel(s).

Overview

Clinical treatment of vascular disease can involve surgical,pharmaceutical, or catheter-based therapies. Surgical methods fortreating vascular occlusive disease tend to be highly invasive and aretypically associated with long hospital stays and high costs.Pharmaceutical treatment using dissolving drugs takes time to work, caninadvertently cause bleeding elsewhere in a patient's body, and canundesirably dislodge large particles of obstructive material.Catheter-based therapies use various mechanisms to fragment, displace orremove vascular obstructions and offer shortened procedure times andreduced hospital stays.

The present inventors recognize that traditional catheter-basedtherapies have many shortcomings. For example, traditionalcatheter-based therapies configured to break down obstructive materialprior to aspiration require expensive capital equipment (such as amotor-turned wire or ultrasonic waves) and routine maintenance. Manyother traditional catheter-based therapies seek to remove obstructivematerial without first breaking it down, which can lead to the catheterbecoming plugged with obstructive material and having to be removed fromthe treatment site and cleaned before continued use. The presentinventors further recognize that traditional catheter-based therapiesfor removing obstructive material have limited suction profiles orsuction power.

The present assemblies provide a single, disposal tool for breakingdown, capturing, and removing obstructive material without requiringexpensive capital equipment or maintenance. The assemblies can be usedto remove a number of obstructive materials from a number of differenttreatment sites within a patient's body before being removed. Anassembly can include an elongate inner member, an elongate outer member,an aspirator, one or more valves, and a waste collection reservoir. Eachof the elongate members can extend from a proximal end portion to adistal end portion and can include a lumen therethrough. The elongateinner member can be partially disposed in the lumen of the elongateouter member and can be moveable along its longitudinal axis relative tothe elongate outer member. The aspirator can be in flow communicationwith the proximal end portion of the elongate inner member for drawingthe obstructive material into or through its lumen. The one or morevalves can be configured and positioned to allow obstructive materialremoved from the body to be urged toward the waste collection reservoir.

The present methods provide steps for breaking down, capturing, andremoving obstructive material from a body vessel or cavity. A method caninclude percutaneously advancing a distal end of an assembly, includingan elongate inner member and a surrounding elongate outer member, to alocation proximate to the obstructive material to be removed. Theelongate inner member can be moved relative to the elongate outer memberalong its longitudinal axis to break down the obstructive materialand/or to draw the occlusive material into a lumen of the elongate innermember. An aspirator, in flow communication with a proximal end of theelongate inner member, can be activated to capture and remove theobstructive material through the lumen of the elongate inner member anddirect the material to a waste collection reservoir.

These and other examples and features of the present assemblies andmethods will be set forth in the following Detailed Description. ThisOverview is intended to provide non-limiting examples of the presentsubject matter—it is not intended to provide an exclusive or exhaustiveexplanation. The Detailed Description below is included to providefurther information about the present assemblies and methods.

BRIEF DESCRIPTION OF THE DRAWINGS

In the drawings, like numerals can be used to describe similar featuresand components throughout the several views. The drawings illustrategenerally, by way of example, but not by way of limitation, embodimentsdiscussed in the present patent document.

FIGS. 1A-B respectively illustrate schematic views of obstructivematerial formations within a deep peripheral vein and a pulmonaryartery.

FIG. 2 illustrates an assembly for one or more of breaking down,capturing, and removing obstructive material from a vessel, asconstructed in accordance with at least one embodiment.

FIG. 3 illustrates a valve manifold for directing negative and positivepressures created by an assembly, as constructed in accordance with atleast one embodiment.

FIGS. 4A-B illustrate schematic views of relative movements between anelongate inner member and an elongate outer member, as constructed inaccordance with at least one embodiment.

FIG. 5 illustrates a schematic view of obstructive material shearing andbodily fluid turbulence caused by movements of an elongate inner memberand one or more orifices in its distal end portion, as constructed inaccordance with at least one embodiment.

FIGS. 6A-C illustrate schematic views of relative movements between anelongate inner member and an elongate outer member, as constructed inaccordance with at least one embodiment.

FIGS. 7-8 illustrate aspirators for creating negative and positivepressures at a proximal end portion of an elongate inner member, asconstructed in accordance with at least two embodiments.

FIG. 9 illustrates a method of breaking down, capturing, and removingobstructive materials from a body vessel or other cavity, as constructedin accordance with at least one embodiment.

The drawing figures are not necessarily to scale. Certain features andcomponents may be shown exaggerated in scale or in schematic form andsome details may not be shown in the interest of clarity andconciseness.

DETAILED DESCRIPTION

The present assemblies and methods provide a single tool to aspirate avessel or other cavity of a patient without the need for surgicalintervention. When obstructive material is too large to be pulled intothe lumen of an elongate inner member using proximally-created suction(negative pressure) alone, a first assembly embodiment allows anelongate inner member to be moved relative to a surrounding elongateouter member to break down the material's size. A combination of suctionand shearing can be performed together or serially so that theobstructive material can be removed from the vessel or cavity anddirected to a waste collection reservoir. According to a second assemblyembodiment, an elongate inner member can be moved relative to asurrounding elongate outer member to create suction at a distal endportion of the assembly. This suction, alone or in combination withproximally-created suction, can be used to pull the obstructive materialinto and through the elongate inner member and ultimately direct it to awaste collection reservoir.

FIGS. 1A-B illustrate schematic views of obstructive material 102formations within a vessel 104 (vein or artery) that can be aspiratedusing the present assemblies and methods. FIG. 1A illustrates a deepvein thrombosis (DVT) that can occur when obstructive material 102 inthe form of a blood clot forms in one or more deep veins 104 of apatient's body. In the example shown, the blood clot can form below avenous valve 108 in a leg 110. Deep vein thrombosis is a seriouscondition that, if left untreated, can partially break loose, travelthrough the bloodstream in a direction 106 toward the patient's heartand lodge in the pulmonary artery 104 of a lung 112, blocking blood flowand causing a pulmonary embolism (PE), as illustrated in FIG. 1B.Pulmonary embolisms can be life-threatening, but prompt treatment cangreatly reduce the risk of death. Taking measures to aspirate bloodclots in the legs 110 can help protect against PE. While the presentassemblies and methods can find use in the treatment of DVT and PE, itis to be understood that use of the assemblies and methods is notlimited to deep veins or pulmonary arteries and can be used to aspiratevessels and cavities throughout the body.

FIG. 2 illustrates an assembly 200 for one or more of breaking down,capturing, and removing obstructive material from a vessel. The assemblycan include an elongate outer member 220, an elongate inner member 218,an aspirator 214, a valve manifold 216, and a waste collection reservoir224. Each of the elongate inner 218 and outer 220 members can extendfrom a proximal end portion to a distal end portion and can include alumen therethrough. The elongate inner member 218 can be partiallydisposed in the lumen of the elongate outer member 220 and can bemovable along its longitudinal axis relative to the elongate outermember 220. The aspirator 214 and the valve manifold 216 can be in flowcommunication with the proximal end portion of the elongate inner member218 and the waste collection reservoir 224 for selectively drawing theobstructive material through the lumen of the elongate inner member 218and directing such material to the waste collection reservoir 224.Extension tubing 219 can be used to facilitate these connections. Aone-way valve in communication with the lumen of the elongate innermember 218 and allowing flow in a distal-to-proximal direction towardthe aspirator 214 can be located within the valve manifold 216 (see FIG.3) or the distal end portion of the elongate outer member 220 (see FIGS.6A-C).

The elongate inner 218 and outer 220 members can have shapes that aresized and configured to facilitate their relative movements andplacement within the vessel. The elongate inner member 218 can have atubular shape with an outer diameter sized so that it can be insertedinto the lumen of a tubular elongate outer member 220. The outer layerof the elongate inner member 218 and the inner layer of the elongateouter member 220 can be composed of low-frictional materials such aspolytetrafluoroethylene (PTFE). At least the elongate outer member 220can include a reinforcing layer composed of braided or wound fibers,strands or wraps for added pushability and torque strength. A radiopaquemarker band or other externally visible component can be located on oneor both of the elongate inner 218 and outer 220 members, such as inclose proximity to their distal end portions for positioning purposes.The distal end portions of the elongate members 218, 220 can be composedof a flexible plastic material that minimizes mechanical trauma to thetreated vessel. Optionally, the elongate outer member 220 can include apre-curved configuration in its unbiased state to conform to a vessel orother body cavity in which the assembly 200 is to be positioned.

The assembly 200 can be percutaneously introduced into the vessel andadvanced such that its distal end portion can be located proximate toobstructive material to be aspirated and its proximal end portion can belocated outside the patient's body. The length of the assembly 200, andparticularly the elongate inner 218 and outer 220 members, can dependupon a desired application. For example, elongate member lengths in therange of 120 cm to 140 cm or more can be used in femoral accesspercutaneous transluminal coronary applications. Intracranial and otherapplications may call for different elongate member lengths dependingupon the vascular access site used. A stopcock 222 at the proximal endportion of the elongate outer member 220 can be used to flush portionsof the assembly before, during or after its introduction within thebody.

FIG. 3 illustrates a cross-section of a valve manifold 316 asconstructed for use with at least one embodiment of the presentassemblies. The valve manifold 316 can direct negative pressure createdby an aspirator 314 through a lumen of an elongate inner member 318 andcan further direct positive pressure created by the aspirator 314 on theobstructive material removed from a vessel and direct it to a wastecollection reservoir 324. The valve manifold 316 can be configured toallow single operator control over the present assemblies, can be usedfor multiple obstructive material withdrawals during a single procedure,and can be made from materials that make it cost effective for disposal.

The valve manifold 316 can include first 332, second 334 and third 330ports. The first port 332 can be attached to a proximal end portion ofthe elongate inner member 318. The second port 334 can be attached tothe waste collection reservoir 324. The third port 330 can be attachedto the aspirator 314. The aspirator can include a plunger 378 and asyringe barrel 315. The plunger 378 can be slidable in the syringebarrel 315 for producing the necessary negative and positive pressuresto remove obstructive material from the vessel or cavity via the firstport 332 and direct such material to the second port 334 and the wastecollection reservoir 324.

The valve manifold 316 can further include first 326 and second 328one-way valves. The first 326 and second 328 one-way valves can bepositioned within the first 332 and second 334 ports, respectively. Thefirst one-way valve 326 can be configured to move from a closed positionto an open position in response to a predetermined negative pressurelevel created by the aspirator 314 through retraction (or proximalmovement) of a plunger 378 and directed to the lumen of the elongateinner member 318. When opened, obstructive material and bodily fluid canbe permitted to enter a distal end portion of the elongate inner member318 and flow proximally into the syringe barrel 315 of the aspirator314. The second one-way valve 328 can be configured to move from aclosed position to an open position in response to a predeterminedpositive pressure level created by advancement (or distal movement) ofthe plunger 378, which urges collected obstructive material and bodilyfluid from the aspirator 314 toward the waste collection reservoir 324.Alternatively, the first one-way valve can be positioned within a distalend portion of an elongate outer member, adjacent and distal to thedistal end portion of the elongate inner member, such that the valvemanifold 316 solely includes the second one-way valve 328 (see FIGS.6A-C).

FIGS. 4A-B illustrate schematic views of an elongate inner member 418and an elongate outer member 420 advanceable into a vessel or othercavity using a guidewire 436, as constructed in accordance with at leasta first embodiment of the present assemblies. As shown in FIG. 5, thisfirst embodiment allows for the shearing of obstructive material that istoo large to be removed in whole by the elongate inner member 418. Eachof the elongate inner 418 and outer 420 members can extend from aproximal end portion 444, 440 to a distal end portion 446, 442 and caninclude a lumen therethrough. The distal end portion 446, 442 of one orboth of the elongate inner member 418 and the elongate outer member 420can include a skived opening 451, 453 leading into its respective lumen.A least part of the distal end portion 442 of the elongate outer member420 can include a sleeve 438 forming a second lumen sized and shaped toreceive a portion of the guidewire 436. Alternatively, the second lumencan be integrated within the confines of the outer surface of theelongate outer member 420 (see FIGS. 6A-C). The distal end portion 446of the elongate inner member 418 can include a wall having a pluralityof orifices 448 therethrough. The orifices 448 can produce turbulentflow of bodily fluids during a treatment procedure, which can facilitateremoval of obstructive material and can be of various shapes (e.g.,round, oval, elliptical, rectangular, triangular or another shapeintended to direct bodily fluid flow in a desired direction) and sizes.

The elongate outer member 420 can be disposed concentrically around theelongate inner member 418, which is disposed within the lumen of theelongate outer member 420. The elongate inner 418 and outer 420 memberscan be arranged such that no appreciable annular gap is provided betweenthe members. Instead, the lumen of the elongate outer member 420 cantightly fit around the outer surface of the elongate inner member 418without gripping it, thereby allowing proximal 452 and distal 450movement of the elongate inner member 418 (relative to the elongateouter member 420) while sealing the lumen of the elongate outer member420. In some examples, the annular gap between the members 418, 420 canbe in the range of 0.01 mm to 0.1 mm. A manipulator or handle 457 can beconnected to the proximal end portions 444, 440 of one or both of theelongate inner 418 and outer 420 members so that clinicians can easilymove the elongate inner member 418 in proximal 452 and distal 450directions relative to the elongate outer member 420.

A length of the elongate inner member 418 can be greater than a lengthof the elongate outer member 420, such as from about 2 cm to 10 cmgreater in length. The greater length allows the distal end portion 446of the elongate inner member 418 to extend beyond that of the elongateouter member 420. As illustrated in FIG. 4A, the distal end portion 446of the elongate inner member 418 can be configured to extend beyond thedistal end portion 442 of the elongate outer member 420, while theproximal end portion 444 of the elongate inner member 418 can beconfigured to concurrently extend proximally of the proximal end portion440 of the elongate outer member 420. Movement restrictors can beprovided at the proximal end portions 444, 440 of the elongate membersto restrict excessive movements of the distal end portion 446 of theelongate inner member 418 out of the distal end portion 442 of theelongate outer member 420. As illustrated in FIG. 4B, the distal endportion 446 of the elongate inner member 418 can subsequently bewithdrawn into the distal end portion 442 of the elongate outer member420 when the proximal end portion 444 of the elongate inner member 418is moved proximally 452.

FIG. 5 illustrates a schematic view of obstructive material 502 shearingand bodily fluid turbulence 555 caused by proximal and distal relativemovements between elongate inner 518 and outer 520 members and one ormore orifices 548 in a distal end portion 546 of the elongate innermember 518. The distal end portions 546, 542 of the elongate inner 518and outer 520 members can be guided through a vessel 504 to a site ofthe obstructive material 502 using a guidewire 536. At this position,relative elongate member 518, 520 movements can provide a mechanicalmechanism for shearing and breaking down the obstructive material 502prior to its aspiration through a lumen of the elongate inner member518. Blood and other bodily fluid flowing into the distal end portion546 of the elongate inner member 518 can be discharged 554 through theone or more orifices 548 toward the wall of the vessel 504 to impingeand further break up obstructive material 502 deposits. The bodily fluidturbulence 555 can urge obstructive material particles 558 into 556 andthrough 560 the lumen of the elongate inner member 518.

A clinician can activate an aspirator in flow communication with aproximal end portion of the elongate inner member 518 to apply anegative pressure to the lumen of the elongate inner member 518. Thisnegative pressure can draw the obstructive material particles 558proximally toward the aspirator. Through the combined action of theobstructive material 502 shearing, bodily fluid turbulence 555, andproximal drawing of obstructive material particles 558, the vessel 504can be adequately treated without having to remove the elongate members518, 520 from the patient's body mid-procedure to be unplugged orotherwise cleaned before continued use. Once the obstructive material502 is adequately captured and removed, the distal end portions 546, 542of the elongate inner 518 and outer 520 members can be advanced to a newtreatment site and used to break down, capture, and remove otherobstructive material.

FIGS. 6A-C illustrate schematic views of an elongate inner member 618and an elongate outer member 620 advanceable into a vessel or othercavity over a guidewire 636, as constructed in accordance with at leasta second embodiment of the present assemblies. This second embodimentallows for the creation of suction at a distal end portion 646 of theelongate inner member 618 to help pull the obstructive material into andthrough the member. Similar to the first embodiment illustrated in FIGS.4A-B and 5, each of the elongate inner 618 and outer 620 members canextend from a proximal end portion 644, 640 to a distal end portion 646,642 and can include a lumen therethrough. The distal end portion 642 ofat least the elongate outer member 620 can include a skived opening 653leading into its lumen. The distal end portions 646, 642 of the elongateinner 618 and outer 620 members can be guided through the vessel orcavity to a site of the obstructive material.

The elongate outer member 620 can be disposed concentrically around theelongate inner member 618, which can be disposed within the lumen of theelongate outer member 620. The elongate inner 618 and outer 620 memberscan be arranged such that the lumen of the elongate outer member 620tightly fits around the outer surface of the elongate inner member 618without gripping it, thereby allowing proximal 652 and distal 650movements of the elongate inner member 618 (relative to the elongateouter member 620) while sealing the lumen of the elongate outer member620.

A length of the elongate inner member 618 can be configured such thatthe distal end portion 646 of the elongate inner member 618 extendswithin the distal end portion 642 of the elongate outer member 620,while the proximal end portion 644 of the elongate inner member 618extends proximally of the proximal end portion 640 of the elongate outermember 620. A one-way valve 626 can be positioned within the distal endportion 642 of the elongate outer member 620, adjacent and distal to thedistal end portion 646 of the elongate inner member 618.

Relative elongate member 618, 620 movements can provide a mechanicalmechanism for urging obstructive material into and through the lumen ofthe elongate inner member 618. The one-way valve 626 can be configuredto move from a closed position (see FIG. 6A) to an open position (seeFIG. 6B) in response to a predetermined negative pressure level createdby the relative movements of the elongate members 618, 620 and/oractivation of an aspirator 614 in flow communication with a proximal endportion 644 of the elongate inner member 618. The negative pressure candraw the obstructive material proximally. For example, the one-way valve626 can be caused to move from the closed position to the open positionthrough retraction (or proximal movement 652) of the elongate innermember 618 relative to the elongate outer member 620. This retraction ofthe elongate inner member 618 creates a cavity to receive obstructivematerial, flowing from a location distal of the one-way valve 626 to alocation proximal of the valve, between the distal end portion 646 ofthe elongate inner member 618 and the one-way valve 626. Subsequentadvancement (or distal movement 650) of the elongate inner member 618relative to the elongate outer member 620 can cause the one-way valve626 to move from the open position (see FIG. 6B) to the closed position(see FIG. 6C) and can further cause the obstructive material proximal ofthe valve 626 to be urged through the lumen of the elongate inner member618 toward its proximal end portion 644. Once the obstructive materialis captured and removed (e.g., by being directed to a waste collectionreservoir), the distal end portions 646, 642 of the elongate inner 618and outer 620 members can be advanced to a new treatment site and usedto capture and remove other obstructive material.

The ability to distally create negative pressure through relativeelongate member 618, 620 movements can provide an assembly with a numberof advantages. First, a clinician using the assembly does not need torely on activation of a proximally-positioned aspirator for the negativepressure used to capture and remove obstructive material. Second,transmission losses associated with negative pressure created at aproximal end portion of the assembly can be avoided. Third, the strengthand profile of the negative pressure felt by obstructive material at atreatment site and urged into the assembly can be enhanced through thecombined efforts of relative elongate member movements and aspiratoractivation.

FIGS. 7 and 8 illustrate aspirators 714, 814 for coupling to a proximalend portion of an elongate inner member. The aspirators 714, 814 can beused to create proximally-directed negative pressure anddistally-directed positive pressure. Each aspirator 714, 814 can includea syringe barrel 715, 815, a plunger 778, 878 slidable in the syringebarrel, and a resilient means 776, 876 configured to urge the plungertoward a resting position. The syringe barrel 715, 815 can extend from aproximal end 765, 865 to a distal end 764, 864. Along the majority ofits length, the syringe barrel 715, 815 can be substantially uniform inboth cross-sectional shape and cross-sectional dimension. The distal end764, 864 of the syringe barrel 715, 815 can be tapered. The distal end764, 864 of the syringe barrel 715, 815 can be coupled to the proximalend portion of the elongate inner member directly or indirectly via avalve manifold (FIG. 3). The plunger 778, 878 can be an elongate memberwith a tip at its distal end. The resilient means 776, 876 can include aspring member. In the example of FIG. 7, the spring member is configuredto urge the plunger 778 to a resting position in which the plunger's tipis at a retracted position in the syringe barrel 715. In the example ofFIG. 8, the spring member is configured to urge the plunger 878 to aresting position in which the plunger's tip is at a depressed positionin the syringe barrel 815.

The aspirators 714, 814 can be controlled by a single hand 770, 870 ofthe clinician, such as through converging movements of fingers 772, 872and a thumb 774, 874. Finger and thumb rings can be configured tofacilitate the converging movements. In the example of FIG. 7, when thetip of the plunger 778 is fully or almost fully retracted out of thesyringe barrel 715, finger 762 and thumb 768 rings are spaced apart fromone another on telescopically slidable members, with the finger rings762 positioned on the proximal end 765 of the syringe barrel 715 and thethumb ring 768 positioned on the proximal end of the plunger 778. In theexample of FIG. 8, when the tip of the plunger 878 is fully or almostfully depressed within the syringe barrel 815, finger and thumb ringsare spaced apart from one another on a scissor-grip handle that includestwo members 869, 871 and three pivot connection points 873, 875, 877.The first pivot connection point 873 can be between the first handlemember 869 and the syringe barrel 815. The second pivot connection point875 can be between the second handle member 871 and the plunger 815. Andthe third pivot connection point 877 can be between the first 869 andsecond 871 handle members. Optionally, one or both of the handle members869, 871 can be bent to facilitate being gripped by the clinician. Theshapes of the handle members 869, 871 and placement of the pivotconnection points 873, 875, 877 can provide leverage to decrease theamount of force that must be exerted by the clinician's hand to move theplunger 878 relative to the syringe barrel 815.

Converging movements of the clinician's fingers 772, 872 and thumb 774,874 can cause the plunger 778, 878 to be advanced into the syringebarrel 715 (see FIG. 7) or retracted out of the syringe barrel 815 (seeFIG. 8). In each case, the resilient means 776, 876 urges the tip of theplunger 778, 878 back to its predetermined resting position. When theplunger 778, 878 is retracted out of the syringe barrel 715, 815,negative pressure is created at the distal end 764, 864 of the syringebarrel 715, 815 that draws obstructive material and bodily fluid througha lumen of the elongate inner member and into the syringe barrel 715,815. When the plunger 778, 878 is advanced (or depressed) into thesyringe barrel 715, 815, positive pressure is created at the distal end764, 864 of the syringe barrel 715, 815 that urges the obstructivematerial and bodily fluid within the syringe barrel 715, 815 toward awaste collection reservoir. The amount of negative or positive pressurecreated by the aspirator 714, 814 can be controlled by controlling thedistance that the fingers 772, 872 and thumb 774, 874 are forcedtogether.

FIG. 9 illustrates a method 980 of breaking down, capturing, andremoving obstructive materials from a body vessel or other cavity. At982, a distal end of an assembly, including (among other things) anelongate inner member and a surrounding elongate outer member, can beadvanced to a first location within the vessel or cavity proximate toobstructive material to be removed. The distal end of the assembly canbe guided to the first location along a pre-advanced guidewire. In anexample, the first location is within a peripheral vessel. In anotherexample, the first location is within a pulmonary artery.

Obstructive material at different locations within the body can be verydifferent from one another. For example, some obstructive material canremain cohesive on removal, while other materials easily break up intosmaller portions when any removal force (negative pressure) is appliedto them. With existing catheter-based capture devices, a clinician mayhave to carry out a number of removal operations in order to remove asingle site of obstructive material, each operation involving theintroduction of the capture device, capture of part of the obstructivematerial, and removal of the device from the patient. Repetition ofthese introduction and removal steps can be time consuming and can causediscomfort for the patient.

The present methods allow obstructive material at a site within the bodyto be adequately removed during a single introduction procedure byleveraging relative movements between the elongate inner and outermembers, at 984. In an example, moving the elongate inner memberrelative to the elongate outer member can include cutting, fragmenting,or otherwise breaking down the obstructive material before aspiratingit. The elongate inner member can include a length greater than a lengthof the elongate outer member, thereby allowing the distal end of theelongate inner member to be moved distally and extend beyond that of theelongate outer member to shear the obstructive material. In anotherexample, moving the elongate inner member relative to the elongate outermember can include creating negative pressure near the distal end of theassembly to draw the obstructive material into and through a lumen ofthe elongate inner member. When the elongate inner member is retracted(or moved proximally), negative pressure at the distal end of theassembly can result.

At 986, an aspirator in flow communication with a proximal end of theelongate inner member can be activated to create negative pressure anddraw obstructive material through the lumen of the elongate innermember. The aspirator can be activated to create negative pressure priorto, concurrently with, or after movements of the elongate inner memberrelative to the elongate outer member. After the obstructive material ismoved through the elongate inner member to a syringe barrel of theaspirator, the aspirator, at 988, can be activated to create positivepressure and urge the obstructive material into a waste collectionreservoir.

At 990, the assembly can be moved from the first location to a differentsecond location proximate to other obstructive material to be removedwithout having to withdraw and reintroduce the assembly. At the secondlocation, method steps 984, 986 and 988 can be repeated.

Closing Notes:

The present assemblies and methods can be used to break down, capture,and remove obstructive material without requiring expensive capitalequipment and maintenance and without the need for surgicalintervention. A number of obstructive materials can be removed from anumber of different sites within a patient's body before the assembly isremoved. Relative movements between elongate inner and outer members canbreak down and/or capture obstructive material within a lumen of theelongate inner member via a prolonged or distally-created suctionprofile. An aspiration source in flow communication with the lumen ofthe elongate inner member can move the obstructive material through suchlumen and toward a waste collection reservoir.

The above Detailed Description includes references to the accompanyingdrawings, which form a part of the Detailed Description. The DetailedDescription should be read with reference to the drawings. The drawingsshow, by way of illustration, specific embodiments in which the presentassemblies and methods can be practiced. These embodiments are alsoreferred to herein as “examples.”

The Detailed Description is intended to be illustrative and notrestrictive. For example, the above-described examples (or one or morefeatures or components thereof) can be used in combination with eachother. Other embodiments can be used, such as by one of ordinary skillin the art upon reviewing the above Detailed Description. Also, variousfeatures or components have been or can be grouped together tostreamline the disclosure. This should not be interpreted as intendingthat an unclaimed disclosed feature is essential to any claim. Rather,inventive subject matter can lie in less than all features of aparticular disclosed embodiment. Thus, the following claim examples arehereby incorporated into the Detailed Description, with each examplestanding on its own as a separate embodiment:

In Example 1, an assembly for removing obstructive material from a bodyvessel or other cavity can include an elongate inner member, an elongateouter member, and an aspirator. Each of the elongate members can extendfrom a proximal end portion to a distal end portion and can include alumen therethrough. The elongate inner member can have a wall includinga plurality of orifices at its distal end portion and can be partiallydisposed in the lumen of the elongate outer member. The elongate innermember can be moveable along its longitudinal axis relative to theelongate outer member such that the plurality of orifices is extendablebeyond, and retractable within, the distal end portion of the elongateouter member. The aspirator can be in flow communication with theelongate inner member for drawing the obstructive material into andthrough the lumen of the elongate inner member.

In Example 2, the assembly of Example 1 can optionally further comprisea first one-way valve and a second one-way valve. The first one-wayvalve can be in communication with the lumen of the elongate innermember to allow flow in a distal-to-proximal direction toward theaspirator. The second one-way valve can allow flow in a direction awayfrom the aspirator and toward a waste collection reservoir.

In Example 3, the assembly of any one of Examples 1 or 2 can optionallyfurther comprise a manipulator handle coupled to the proximal endportion of one or both of the elongate inner member and the elongateouter member to allow advancement and retraction of the elongate innermember relative to the elongate outer member.

In Example 4, the assembly of any one or any combination of Examples 1-3can optionally further comprise a radiopaque marker positioned on thedistal end portion of one or both of the elongate inner member and theelongate outer member.

In Example 5, the assembly of any one or any combination of Examples 1-4can optionally be configured such that the lumen of the elongate outermember tightly fits around the outer surface of the elongate innermember without gripping it, thereby allowing the elongate inner memberto move relative to the elongate outer member while sealing the lumen ofthe elongate outer member.

In Example 6, the assembly of any one or any combination of Examples 1-5can optionally be configured such that a wall of the elongate outermember includes a reinforcing layer composed of braided or wound fibers.

In Example 7, the assembly of any one or any combination of Examples 1-6can optionally be configured such that the distal end portion of theelongate outer member includes a second lumen, which is non-coaxial withits other lumen and is sized and shaped to receive a portion of aguidewire.

In Example 8, the assembly of any one or any combination of Examples 1-7can optionally be configured such that the distal end portion of one orboth of the elongate inner member and the elongate outer member includesa skived distal tip opening into its lumen.

In Example 9, the assembly of any one or any combination of Examples 1-8can optionally be configured such that the plurality of orificesincludes at least three radially-spaced orifices, each orifice having anoval or elliptical shape.

In Example 10, the assembly of any one or any combination of Examples1-9 can optionally be configured such that the aspirator includes asyringe barrel, a plunger slidable in the syringe barrel, and aresilient means, the resilient means configured to urge the plungertoward a resting position.

In Example 11, an assembly for removing obstructive material from a bodyvessel or other cavity can include an elongate inner member and anelongate outer member. Each of the elongate members can extend from aproximal end portion to a distal end portion and can include a lumentherethrough. The elongate inner member can be partially disposed in thelumen of the elongate outer member and can be moveable along itslongitudinal axis relative to the elongate outer member such that itsdistal end portion is extendable beyond, and retractable within, thedistal end portion of the elongate outer member. The elongate outermember can include a second lumen at its distal end portion. The secondlumen can be non-coaxial with the lumen in which the elongate innermember is disposed and sized and shaped to receive a portion of aguidewire.

In Example 12, the assembly of Example 11 can optionally furthercomprise an aspirator in flow communication with the elongate innermember for drawing the obstructive material through the lumen of theelongate inner member.

In Example 13, the assembly of Example 12 can optionally be configuredsuch that the aspirator includes a syringe barrel, a plunger slidable inthe syringe barrel, and a resilient means. The resilient means can beconfigured to urge the plunger toward a resting position.

In Example 14, the assembly of any one of Examples 11 or 12 canoptionally further comprise a first one-way valve and a second one-wayvalve. The first one-way valve can be in communication with the lumen ofthe elongate inner member to allow flow in a distal-to-proximaldirection toward the aspirator. The second one-way valve can allow flowin a direction away from the aspirator and toward a waste collectionreservoir.

In Example 15, the assembly of any one or any combination of Examples11-14 can optionally further comprise a manipulator handle coupled tothe proximal end portion of one or both of the elongate inner member andthe elongate outer member to allow advancement and retraction of theelongate inner member relative to the elongate outer member.

In Example 16, the assembly of any one or any combination of Examples11-15 can optionally be configured such that the elongate inner memberhas a wall including an orifice at its distal end portion. The orificecan have an axis extending at an angle to an extension axis of theelongate inner member.

In Example 17, a method for removing obstructive material from a firstlocation with a body vessel or cavity can include percutaneouslyadvancing a distal end of an assembly, which includes an elongate innermember and a surrounding elongate outer member, to the first location.The elongate inner member can be moved relative to the elongate outermember along its longitudinal axis. This movement can include axiallyreciprocating a distal end of the elongate inner member betweenpositions beyond and within a distal end of the elongate outer member.An aspirator in flow communication with a lumen of the elongate innermember can be activated by sliding a plunger relative to a syringebarrel and allowing a resilient member to urge the plunger toward aresting position.

In Example 18, the method of Example 17 can optionally be configuredsuch that percutaneously advancing the distal end of the assembly to thefirst location includes advancing a guidewire lumen of the elongateouter member along a pre-advanced guidewire.

In Example 19, the method of any one of Examples 17 or 18 can optionallybe configured such that axially reciprocating the distal end of theelongate inner member between positions beyond and within the distal endof the elongate outer member includes cutting or fragmenting theobstructive material prior to aspirating it.

In Example 20, the method of any one or any combination of Examples17-19 can optionally be configured such that axially reciprocating thedistal end of the elongate inner member between positions beyond andwithin the distal end of the elongate outer member includes producing aturbulent flow of bodily fluid through movement of a plurality oforifices in a wall of the distal end portion of the elongate innermember.

In Example 21, the method of any one or any combination of Examples17-20 can optionally be configured such that removing the obstructivematerial includes depositing the obstructive material into a wastecollection reservoir in flow communication with the aspirator.

In Example 22, the method of any one or any combination of Examples17-21 can optionally further comprise moving the assembly from the firstlocation to a different second location proximate to other obstructivematerial to be removed without having to withdraw and reintroduce theassembly from the body vessel or cavity. When at the second location,the elongate inner member can be moved relative to the elongate outermember along its longitudinal axis and the aspirator can be activated,thereby removing the obstructive material.

In Example 23, the assembly or method of any one or any combination ofExamples 1-22 can optionally be configured such that all components oroptions recited are available to use or select from.

Certain terms are used throughout this patent document to refer toparticular features or components. As one skilled in the art willappreciate, different persons may refer to the same feature or componentby different names. This patent document does not intend to distinguishbetween components or features that differ in name but not in function.

For the following defined terms, certain definitions shall be appliedunless a different definition is given elsewhere in this patentdocument. The terms “a,” “an,” and “the” are used to include one or morethan one, independent of any other instances or usages of “at least one”or “one or more.” The term “or” is used to refer to a nonexclusive or,such that “A or B” includes “A but not B,” “B but not A,” and “A and B.”The terms “distal” and “proximal” are used to refer to a position ordirection relative to a treating clinician. “Distal” or “distally” referto a position that is further from the treating clinician. Similarly,“advance,” “advancing,” or “depressed” refer to a direction away fromthe treating clinician. “Proximal” and “proximally” refer to a positionthat is closer to the treating clinician. Similarly, “retract” or“retracting” refer to a direction toward the treating clinician. Theterm “patient” refers to a human patient or an animal patient. The term“clinician” refers to a doctor, nurse or other care provider and caninclude support personnel.

The scope of the invention should be determined with reference to theappended claims, along with the full scope of equivalents to which suchclaims are entitled. In the appended claims, the terms “including” and“in which” are used as the plain-English equivalents of the respectiveterms “comprising” and “wherein.” Also, in the following claims, theterms “including” and “comprising” are open-ended; that is, an assembly,kit or method that includes features or components in addition to thoselisted after such a term in a claim are still deemed to fall within thescope of that claim. Moreover, in the following claims, the terms“first,” “second” and “third,” etc. are used merely as labels, and arenot intended to impose numerical requirements on their objects. It is tobe understood that although dependent claims may be set out in singledependent form, the features of these claims can be combined as if theclaims were in multiple dependent form.

The Abstract is provided to allow the reader to quickly ascertain thenature of the technical disclosure. It is submitted with theunderstanding that it will not be used to interpret or limit the scopeor meaning of the claims.

What is claimed is:
 1. An assembly for removing obstructive materialfrom a body vessel or cavity, comprising: an elongate outer member andan elongate inner member, each extending from a proximal end portion toa distal end portion and including a lumen therethrough, the elongateinner member having a wall including a plurality of orifices at itsdistal end portion and partially disposed in the lumen of the elongateouter member, the elongate inner member movable along its longitudinalaxis relative to the elongate outer member such that the plurality oforifices are extendable beyond, and retractable within, the distal endportion of the elongate outer member; and an aspirator in flowcommunication with the elongate inner member for drawing the obstructivematerial through the lumen of the elongate inner member.
 2. The assemblyof claim 1, further comprising: a first one-way valve in communicationwith the lumen of the elongate inner member and allowing flow in adistal-to-proximal direction toward the aspirator; and a second one-wayvalve allowing flow in a direction away from the aspirator and toward awaste collection reservoir.
 3. The assembly of claim 1, furthercomprising a manipulator handle coupled to the proximal end portion ofone or both of the elongate inner member and the elongate outer memberto allow advancement and retraction of the elongate inner memberrelative to the elongate outer member.
 4. The assembly of claim 1,further comprising a radiopaque marker positioned on the distal endportion of one or both of the elongate inner member and the elongateouter member.
 5. The assembly of claim 1, wherein the lumen of theelongate outer member tightly fits around the outer surface of theelongate inner member without gripping it and allowing the elongateinner member to move relative to the elongate outer member while sealingthe lumen of the elongate outer member.
 6. The assembly of claim 1,wherein a wall of the elongate outer member includes a reinforcing layercomposed of braided or wound fibers.
 7. The assembly of claim 1, whereinthe distal end portion of the elongate outer member includes a secondlumen, which is non-coaxial with its other lumen and is sized and shapedto receive a portion of a guidewire.
 8. The assembly of claim 1, whereinthe distal end portion of one or both of the elongate inner member andthe elongate outer member includes a skived distal tip opening into itslumen.
 9. The assembly of claim 1, wherein the plurality of orificesincludes at least three radially-spaced orifices, each having an oval orelliptical shape.
 10. The assembly of claim 1, wherein the aspiratorincludes a syringe barrel, a plunger slidable in the syringe barrel, anda resilient means, the resilient means configured to urge the plungertoward a resting position.
 11. An assembly for removing obstructivematerial from a body vessel or cavity, comprising: an elongate outermember and an elongate inner member, each extending from a proximal endportion to a distal end portion and including a lumen therethrough, theelongate inner member partially disposed in the lumen of the elongateouter member and movable relative to the elongate outer member such thatits distal end portion is extendable beyond, and retractable within, thedistal end portion of the elongate outer member, and the elongate outermember including a second lumen at its distal end portion, the secondlumen non-coaxial with the lumen in which the elongate inner member isdisposed and sized and shaped to receive a portion of a guidewire. 12.The assembly of claim 11, further comprising an aspirator in flowcommunication with the elongate inner member for drawing the obstructivematerial through the lumen of the elongate inner member.
 13. Theassembly of claim 12, wherein the aspirator includes a syringe barrel, aplunger slidable in the syringe barrel, and a resilient means, theresilient means configured to urge the plunger toward a restingposition.
 14. The assembly of claim 12, further comprising: a firstone-way valve in communication with the lumen of the elongate innermember and allowing flow in a distal-to-proximal direction toward theaspirator; and a second one-way valve allowing flow in a direction awayfrom the aspirator and toward a waste collection reservoir.
 15. Theassembly of claim 11, further comprising a manipulator handle coupled tothe proximal end portion of one or both of the elongate inner member andthe elongate outer member to allow advancement and retraction of theelongate inner member relative to the elongate outer member.
 16. Theassembly of claim 11, wherein the elongate inner member has a wallincluding an orifice at its distal end portion, the orifice having anaxis extending at an angle to an extension axis of the elongate innermember.
 17. A method, comprising: percutaneously advancing a distal endof an assembly, including an elongate inner member and a surroundingelongate outer member, to a first location within a body vessel orcavity proximate to obstructive material to be removed; moving theelongate inner member relative to the elongate outer member along itslongitudinal axis, including axially reciprocating a distal end of theelongate inner member between positions beyond and within a distal endof the elongate outer member; activating an aspirator in flowcommunication with a lumen of the elongate inner member, includingsliding a plunger relative to a syringe barrel and allowing a resilientmember to urge the plunger toward a resting position; and removing theobstructive material from the first location within the body vessel orcavity.
 18. The method of claim 17, wherein percutaneously advancing thedistal end of the assembly to the first location includes advancing aguidewire lumen of the elongate outer member along a pre-advancedguidewire.
 19. The method of claim 17, wherein axially reciprocating thedistal end of the elongate inner member between positions beyond andwithin the distal end of the elongate outer member includes cutting orfragmenting the obstructive material prior to aspirating it.
 20. Themethod of claim 17, wherein axially reciprocating the distal end of theelongate inner member between positions beyond and within the distal endof the elongate outer member includes producing a turbulent flow ofbodily fluid through movement of a plurality of orifices in a wall ofthe distal end portion of the elongate inner member.
 21. The method ofclaim 17, wherein removing the obstructive material includes depositingthe obstructive material into a waste collection reservoir in flowcommunication with the aspirator.
 22. The method of claim 17, furthercomprising: moving the assembly from the first location to a differentsecond location proximate to other obstructive material to be removed,without having to withdraw and reintroduce the assembly from the bodyvessel or cavity; moving the elongate inner member relative to theelongate outer member along its longitudinal axis; activating theaspirator; and removing the obstructive material from the secondlocation within the body vessel or cavity.